FDA - The MedTech Scribe

FDA

A Quick Look at a Critical FDA Discussion Paper

It seems a good time to update everyone on the FDA discussion paper for autonomous and remote teleoperation surgical systems. There’s a lot in this paper that I won’t go into here, but here are a few matters worth mentioning. First, the FDA’s Center for Devices and

Enforcement

A Blast From the Past: FDA's Recurring Commercial Speech Problem

(Posted Sept. 22, 2026, on LinkedIn) The world of prescription drug advertising is indisputably a world unto itself, but both the Department of Health and Human Services and FDA seem determined to reel in such advertising. FDA released a batch of warning letters to manufacturers last year on that subject,

Artificial intelligence

Notes from the MDMA Annual Meeting in D.C.

(Posted April 30, 2026, on LinkedIn) I'm here at the annual meeting of the Medical Device Manufacturers Association in Washington, D.C., and here are a few notes about remarks by FDA commissioner Marty Makary. Makary discussed a number of subjects related to pharma and biotech along with

FDA

New FDA Programs Full of Promise, but Pitfalls Loom

(Published April 13, 2026, on LinkedIn) FDA has rolled out several new programs recently that promise to cut red tape for medical product applications to improve patient access. Still, Nate Downing of Gardner Law told me in an interview that while these programs have much to offer, manufacturers shouldn’t